The draft EU machinery regulation

Challenges for machine manufacturers

On 21.4.2021, the EU Commission presented the proposal for a "Machinery Products Regulation" (COM(2021) 202 final). The planned regulation is to replace the previous Machinery Directive 2006/42/EC (MRL for short). This does not comply with the requirements of Decision 768/2008/EC ("New Legislative Framework") and should therefore be adapted in the same way as other harmonization legislation such as the Low Voltage Directive.

For example, the MRL used different definitions. In analyzing the draft, Recital 40 stands out: "In the absence of relevant harmonized standards, the Commission should have the possibility to establish technical specifications for the essential health and safety requirements. Recourse to technical specifications should be used as a fallback solution to facilitate the manufacturer's obligation to comply with the health and safety requirements, for example where the standardization process is blocked due to a lack of consensus between stakeholders or where there are unacceptable delays in the development of a harmonized standard. Such delays could occur, for example, if the required quality is not achieved."

This is apparently an attempt to exert pressure on the standard-setting institutions (CEN, CENELEC) and can be interpreted as a further effect of the "James Elliott" ruling of the European Court of Justice. A similar approach can already be seen in the new Medical Devices Regulation (see Article 9, 2017/745). The proposal ostensibly outlined 6 problem areas that are not covered in the MRL:

  • 1) Covering new risks associated with emerging digital technologies and potential safety implications,
  • 2) Ensuring a consistent interpretation of the scope and definitions and improving safety in relation to traditional technologies,
  • 3) Re-evaluate high-risk machinery and re-evaluate related conformity assessment procedures,
  • 4) Reducing paper-based documentation requirements (we will take up this topic at our 9th Product Compliance Conference),
  • 5) Ensuring consistency with other product safety legislation,
  • 6) Avoiding divergence in interpretation due to transposition into national law.

Especially topics like collaborating robots, connected machinery (connected via internet), software updates (affecting safety), self-learning machines (artificial intelligence) as well as autonomous machines are gaining importance and are insufficiently or not yet regulated.

Essential health and safety requirements are now defined in Annex III.

The topic of artificial intelligence is newly included in Article 9 as well as in Annex III 1. (c). This Annex III 1. (c) states that "...where an artificial intelligence system is integrated into the machine product, the risk assessment for the machine should take into account the risk assessment for that artificial intelligence system carried out in accordance with Regulation ... of the European Parliament and of the Council  on a European approach to artificial intelligence."

The topic "Cybersecurity" is also newly included with Annex III No. 1.1.9 Protection against falsification:

  • Connection of another device to the product via any function of the connected device itself or via a remote device communicating with the machine product does not lead to a dangerous situation,
  • Hardware component: adequate protection against accidental or intentional falsification,
  • software & data: in case of crucial importance, they shall be designated as such and adequately protected against accidental or intentional tampering,
  • installed software: identify it for secure operation (if required) and provide this information in an easily accessible form at all times.

The challenge for machine manufacturers: the machine product must collect evidence of lawful or unlawful tampering with or modification of software installed in the machine product or its configuration. There are also to be changes in Annex III, No. 1.2.1 related to the reliability of control systems:

  • (d) ... the safety functions cannot be modified beyond the limits specified by the manufacturer in the risk assessment for the machine product. ...
  • (f) ... the traceability log of data generated in connection with an intervention and of versions of the safety software uploaded after the machinery product has been placed on the market or put into service is accessible, for up to five years after uploading, exclusively for the purpose of demonstrating the conformity of the machinery product with this Annex, upon reasoned request by a competent national authority.

Published on 21.07.2021
Category: Fokus Industry, Compliance

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